Medtronic has an extensive and impressive lineup of surgical staplers. Even so, the company recognized there were unique challenges with the standard OR devices as more procedures move toward minimally invasive approaches.
Those challenges drove Medtronic to develop the Signia Stapling System.
To learn more, Surgical Products interviewed Ethan Loiselle, Senior Director of Global Surgical Stapling at Medtronic.
Tell us about some of the unique features of the Signia Stapling System.
Signia has several features that make it unique. Two of the most important of those features include the device being fully-powered and that it’s designed for single-handed use. Until the launch of Signia, all other laparoscopic staplers required two rather than one hand to operate and also required manual control.
Signia’s fully-powered operation allows surgeons, with just the tip of their fingers and thumbs, to open, close, and fire, as well as articulate and rotate the device. Signia is also ambidextrous, enabling surgeons to operate and access all its functions and controls with either their left or right hand.
Another hallmark of Signia is its Adaptive Firing technology. This technology allows the stapler to understand and read the tissue with which it’s interacting, adapting the speed of the device’s firing by measuring tissue thickness and density. This technology is the brains of the device.
What kind of information does the Signia Stapling System provide the surgeon?
In developing Signia, we focused on how the stapler communicates back to the surgeon. All other laparoscopic staplers force surgeons to understand what’s happening during the procedure by the response they feel upon squeezing the tissue with the device. This has a major drawback. The surgeons’ understanding or impression is made at a significant distance from the operating site, making it a challenge to consistently assess the tissue.
Signia addresses this challenge by providing surgeons with feedback about what’s happening at the tissue level through an intelligent, handle-mounted LED screen. Throughout a procedure, the device communicates information to the surgeon via the screen. The real-time delivery of this information is possible because Signia features microprocessors and a computer in its handle.
The device also works hand-in-glove with our intelligent reload platform. About a year ago, we launched our Tri-Staple 2.0 chip-enabled reloads. When the reload is attached to Signia’s handle, the handle reads the reload type’s color and length. This determines how the staple is fired and what information the surgeon receives.
What differences will other OR staff notice with the Signia Stapling System?
For the OR staff, the number of times technicians use a surgical device can determine how well they can set it up and how quickly they get it to a surgeon. Accordingly, we designed Signia’s LED screen to communicate to the technicians, walking them through every step of the setup process. For example, the screen’s visual readout tells them how to insert the power pack into the clamshell and how to fit the adapter.
It also tells them how many times the stapler has been fired and if a reload has already been used — an important safety feature that no other device has. If a surgeon fires a reload and the technician reinserts the same reload, Signia will provide a visible indication that the reload has already been fired. None of our reloads can be refired due to a mechanical lockout function. However, Signia takes this a step further, communicating the issue visually to the technician before he or she even puts it in the surgeon’s hands.
From an administrative perspective, Signia also provides a significant benefit with its reusability, having been rated for use in up to 200 procedures. The power pack is enclosed in a disposable powershell, which is a unique Medtronic offering. At the end of the procedure, this outer casing is discarded and the power pack placed back in its battery charger. Signia is then ready for the next case.
How did feedback from surgeons factor into the development of the device?
We devoted an incredible amount of time on both the ergonomics of the handle and the usability of the overall system, reviewing surgeons’ feedback from the beginning of the design process.
First and foremost, we focused our designing efforts on ensuring that the controls were seamless and intuitive, as surgeons wanted to be able to concentrate fully on the procedure and the patient. They did not want to have pay attention to — or even be cognizant of — the controls with which they were interfacing.
The other key consideration was to address how the device would fit in a surgeon’s hands. We tested about 20 different configurations to optimize how the stapler would fit the surgeon’s hand, determining what would be the most comfortable and effective as they use the controls.
We believe this attention to design and comfort has enabled us to keep the learning curve of Signia down. Based on feedback from over 800 clinical cases, surgeons are stating that they are learning how to use the device in only one or two procedures, becoming completely confident in less than five.
How does the Adaptive Firing technology work?
If we think about laparoscopic staplers, in standard non-thick and non-challenging tissue, the speed with which you fire the stapler is not all that significant in terms of clinical performance. However, through testing we’ve done, we also know that, as tissue becomes thicker and more challenging, the speed does play a role in the formation of staples.
What Adaptive Firing technology does is interpret the thickness of the tissue through force. If the stapler is on standard, non-challenging tissue, Signia will fire at normal speed. When it encounters or senses that it’s on thicker tissue, it adjusts the stapler’s firing speed to ensure staple formation is optimized.
Feedback from surgeons about Adaptive Firing technology has been positive. They especially appreciate that, in addition to adjusting firing speed, the LED screen tells them what firing zone they are in. The technology does this by providing the surgeon with an initial reading of the force that it took the stapler to clamp down on the tissue. If the thickest zone of tissue is detected, the surgeon has the option to change the reload selection based on that zone.
Having this advantage is important with laparoscopic procedures. In open procedures, surgeons can directly touch the tissue, which provides them with a sense of how they need to interact with it. During laparoscopic procedures, surgeons’ ability to sense the tissue is definitely muted, as they look down a port and up at a screen. Our aim with Adaptive Firing technology – and Signia – is to give surgeons back the direct knowledge of tissue open procedures provide.
Anything else you’d like to add?
Signia required a fair amount of system engineering and innovation to develop. There are sensors on the device that had to be invented that aren’t used anywhere else in healthcare today. Signia has launched this technology, enabling us to integrate it into new staplers. By far, Signia is superior to any surgical stapler we’ve made to date.